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Class 2 Device Recall InteliFUSE, Drill Bit, 1.50 mm, JLatch |
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Date Initiated by Firm |
July 30, 2008 |
Date Posted |
March 05, 2009 |
Recall Status1 |
Terminated 3 on June 22, 2011 |
Recall Number |
Z-1032-2009 |
Recall Event ID |
49372 |
Product Classification |
Drill Bit - Product Code HTW
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Product |
InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom
Intended Use: Creating of holes for implant placement. |
Code Information |
Lot Nos.: 984266, 78993, N64730, 17262-01, 064798, and 82030. |
Recalling Firm/ Manufacturer |
Intelifuse Inc 1515 Poydras Street Suite 1490 New Orleans LA 70112
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For Additional Information Contact |
Megan Ohar 504-561-1100
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Manufacturer Reason for Recall |
Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.
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FDA Determined Cause 2 |
Process control |
Action |
The firm initiated their recall on July 31, 2008 via telephone and Urgent Recall Notice to their current distributor, Integra. The letter asked them to complete, sign, and return the enclosed Recall Acknowledgment and Return Form. The letter also stated that InteliFUSE would travel to their designated Distribution Center(s) to ensure testing and replacement of all defective units once the form has been received. The firm sent follow-up Urgent Recall Notice letters on August 14, 2008 directing the distributor to recall from the hospitals to whom they distributed the product and to two hospitals which were shipped the products directly. The letter asked that use of the affected products be immediately ceased and that the any stock on hand be quarantined. The Recall Acknowledgment and Return Form should be completed, signed, and returned and the products should be returned to InteliFUSE for immediate replacement. |
Quantity in Commerce |
2133 units |
Distribution |
Nationwide Distribution - NY and NJ. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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